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Printed Might 04, 2023 • 9 minute learn
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– Key MM-120 readouts in GAD (Section 2b) and ADHD (Section 2a) anticipated by finish of 2023 –
– MM-402 pre-clinical information in ASD mannequin to be offered at ASCP 2023 Annual Assembly –
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– Strengthened management group with appointment of Mark R. Sullivan as Chief Authorized Officer –
– Money and money equivalents of $129.4 million at March 31, 2023 –
– Firm to host convention name right this moment at 4:30 PM ET –
NEW YORK — Thoughts Drugs (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the “Firm” or “MindMed”), a scientific stage biopharmaceutical firm growing novel product candidates to deal with mind well being issues, right this moment reported its monetary outcomes for the quarter ended March 31, 2023.
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“2023 is a crucial yr for MindMed and we’re effectively positioned to proceed advancing our R&D pipeline towards a number of near-term milestones later this yr,” mentioned Robert Barrow, Chief Government Officer and Director of MindMed. “These embody key information from our Section 2b examine of MM-120 for the remedy of generalized anxiousness dysfunction, in addition to from our Section 2a proof-of-concept trial of repeated low-dose MM-120 in attention-deficit/hyperactivity dysfunction. Moreover, we plan to provoke the primary scientific trial of MM-402 later within the yr following optimistic preclinical outcomes, which we plan to current on the ASCP 2023 Annual Assembly. We made nice progress all through the primary quarter and proceed to stay targeted on long-term worth creation for our shareholders by targeted and environment friendly execution.”
Enterprise Replace
- In April 2023, Mark R. Sullivan was appointed as Chief Authorized Officer. Mr. Sullivan involves MindMed with in depth and demonstrated success as a pharmaceutical govt, with explicit experience within the areas of SEC reporting, financing, company governance and compliance, mergers and acquisitions, mental property, litigation administration and enterprise improvement.
- The Firm reiterates its steering for its money runway, which is anticipated to fund its present working plan into the primary half of 2025.
- MindMed’s administration group will take part within the RBC Capital Markets World Healthcare Convention that’s being held in New York, NY from Might 16-17, 2023, the BIO Worldwide Conference being held in Boston, MA from June 5-8, 2023, the Jefferies World Healthcare Convention that’s being held in New York, NY from June 7-9, 2023 in addition to the H.C. Wainwright Neuropsychiatry Convention that’s being held just about on June 26, 2023.
- The Firm plans to host an analyst and investor day within the second quarter of 2023. The occasion will probably be hosted by the Firm’s administration group and can embody a doctor knowledgeable and different key opinion leaders.
Current Highlights and Anticipated Upcoming Milestones:
Section 2b examine evaluating MM-120 for generalized anxiousness dysfunction (“GAD”) stays on observe for late 2023 topline readout
- MM-120, the Firm’s proprietary, pharmaceutically optimized type of lysergide D-tartrate, is being developed for the remedy of GAD.
- In August 2022, the Firm initiated dosing within the 200-patient Section 2b dose-optimization examine of MM-120 for the remedy of GAD.
- Affected person enrollment is presently ongoing, and the examine stays on observe, with topline outcomes anticipated to be introduced in late 2023.
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Section 2a examine evaluating MM-120 for consideration deficit hyperactivity dysfunction (“ADHD”) stays on observe for late 2023 topline readout
- The Firm’s Section 2a proof-of-concept trial for the remedy of ADHD is designed to evaluate the protection and efficacy of repeated low-dose MM-120 administration in 52 sufferers.
- The Firm expects topline ends in late 2023.
Advancing improvement of MM-402 into first scientific trial in 2023
- The Firm is growing MM-402, the Firm’s proprietary type of the R-enantiomer of three,4-Methylenedioxymethamphetamine (“MDMA”), for the remedy of core signs of autism spectrum dysfunction (“ASD”).
- A late breaking summary on the outcomes from a pre-clinical examine of MM-402 in a mannequin of ASD, titled “MM-402, R(−)-3,4-Methylenedioxymethamphetamine, Demonstrates Prosocial and Therapeutic-Like Results in Fmr1 Knockout mice, a Preclinical Mannequin of Autism Spectrum Dysfunction (because of Fragile X syndrome)” has been accepted for presentation on the American Society of Scientific Psychopharmacology (ASCP) 2023 Annual Assembly that’s being held in Miami Seaside, FL from Might 30-June 2, 2023.
- The Firm plans to provoke its first scientific trial of MM-402 in 2023. This Section 1 examine is meant to characterize the tolerability, pharmacokinetics and pharmacodynamics of MM-402, and to guage early alerts of efficacy to help the Firm’s strategy in focusing on core signs of ASD.
- College Hospital Basel (“UHB”) in Switzerland, the Firm’s collaborator, is presently enrolling individuals in a Section 1 investigator-initiated trial of R(-)-MDMA, S(+)-MDMA and R/S-MDMA in wholesome volunteers. This trial compares the tolerability, pharmacokinetics and acute subjective, physiological and endocrine results of the three molecules.
Collaborations and Partnerships
The Firm continues to help its ongoing collaboration with the Liechti Lab at College Hospital Basel (“UHB”) in Switzerland. MindMed has unique worldwide rights to information, compounds and patent rights related to UHB’s analysis on lysergide and different psychedelic compounds, together with information from preclinical research and investigator-initiated scientific trials.
In April 2023, Prof. Matthias Liechti and Dr. Felix Mueller, MindMed collaborators at UHB, launched optimistic topline information from a Section 2 double-blind investigator-initiated scientific trial evaluating two lysergide regimens within the remedy of main depressive dysfunction (MDD). These demonstrated the numerous, fast and useful results of lysergide and its potential to securely mitigate signs of MDD. Sufferers within the excessive dose arm (n=28) demonstrated a least sq. imply change from baseline in clinician-rated Stock of Depressive Symptomatology (IDS-C) scores of -12.9 factors in comparison with -3.6 factors within the decrease dose arm (n=27, p=0.02). The statistically vital profit as measured by IDS-C was maintained as much as 16 weeks after the primary administration in comparison with placebo (p=0.008). Information from the secondary endpoints had been additionally encouraging. The investigational drug was typically well-tolerated, as indicated by reported hostile occasions, modifications in very important indicators and laboratory values.
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First Quarter 2023 Monetary Outcomes
Money Stability. As of March 31, 2023, MindMed had money and money equivalents totaling $129.4 million in comparison with $142.1 million as of December 31, 2022. The Firm believes its out there money and money equivalents will probably be ample to fund its working necessities into the primary half of 2025.
Web Money in Working Actions. The online money utilized in working actions was $13.3 million for the quarter ended March 31, 2023, in comparison with $12.9 million within the quarter ended March 31, 2022.
Analysis and Improvement (R&D). R&D bills had been $12.6 million for the quarter ended March 31, 2023, in comparison with $10.2 million for the quarter ended March 31, 2022, a rise of $2.4 million. The rise was primarily because of will increase of $2.9 million in bills associated to scientific analysis for the MM-120 GAD examine, $0.9 million in bills associated to our MM-402 program, and $0.2 million in inside personnel prices because of rising analysis and improvement capacities, offset by a lower of $0.7 million in bills associated to our MM-110 program, and a lower of $0.9 million of bills in reference to numerous exterior R&D collaborations.
Basic and Administrative (G&A). G&A bills had been $8.3 million for the quarter ended March 31, 2023, in comparison with $8.3 million for the quarter ended March 31, 2022.
Web Loss. Web loss for the quarter ended March 31, 2023 was $24.8 million, in comparison with $18.5 million for a similar interval in 2022.
Convention Name and Webcast Reminder
MindMed administration will host a convention name at 4:30 PM EST right this moment to offer a company replace and assessment the Firm’s first quarter 2023 monetary outcomes. People might take part within the dwell name through phone by dialing (888) 396-8049 (home) or (416) 764-8646 (worldwide). The webcast may be accessed dwell right here on the Financials web page within the Traders part of the MindMed web site, https://mindmed.co/. The webcast will probably be archived on the Firm’s web site for a minimum of 30 days after the convention name.
About MindMed
MindMed is a scientific stage biopharmaceutical firm growing novel product candidates to deal with mind well being issues. Our mission is to be the worldwide chief within the improvement and supply of remedies that unlock new alternatives to enhance affected person outcomes. We’re growing a pipeline of progressive product candidates, with and with out acute perceptual results, focusing on neurotransmitter pathways that play key roles in mind well being issues.
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MindMed trades on NASDAQ beneath the image MNMD and on the Canadian NEO Alternate beneath the image MMED.
Ahead-Trying Statements
Sure statements on this information launch associated to the Firm represent “forward-looking data” inside the that means of relevant securities legal guidelines and are potential in nature. Ahead-looking data is just not primarily based on historic details, however quite on present expectations and projections about future occasions and are due to this fact topic to dangers and uncertainties which may trigger precise outcomes to vary materially from the longer term outcomes expressed or implied by the forward-looking statements. These statements typically may be recognized by way of forward-looking phrases similar to “will”, “might”, “ought to”, “may”, “intend”, “estimate”, “plan”, “anticipate”, “count on”, “imagine”, “potential” or “proceed”, or the unfavorable thereof or comparable variations. Ahead-looking data on this information launch contains, however is just not restricted to, statements concerning anticipated upcoming milestones, trials and research, outcomes and timing of scientific trials, the potential advantages of the Firm’s product candidates, and the Firm’s money runway funding its operations into the primary half of 2025. There are quite a few dangers and uncertainties that might trigger precise outcomes and the Firm’s plans and aims to vary materially from these expressed within the forward-looking data, together with historical past of unfavorable money flows; restricted working historical past; incurrence of future losses; availability of further capital; lack of product income; compliance with legal guidelines and rules; issue related to analysis and improvement; dangers related to scientific trials or research; heightened regulatory scrutiny; early stage product improvement; scientific trial dangers; regulatory approval processes; novelty of the psychedelic impressed medicines trade; in addition to these danger elements mentioned or referred to herein and the dangers described within the Firm’s Annual Report on Kind 10-Okay for the fiscal yr ended December 31, 2022, the Firm’s Quarterly Report on Kind 10-Q for the fiscal quarter ended March 31, 2023 beneath headings similar to “Particular Observe Relating to Ahead-Trying Statements,” and “Danger Elements” and “Administration’s Dialogue and Evaluation of Monetary Situation and Outcomes of Operations” and different filings and furnishings made by the Firm with the securities regulatory authorities in all provinces and territories of Canada which can be found beneath the Firm’s profile on SEDAR at www.sedar.com and with the U.S. Securities and Alternate Fee on EDGAR at www.sec.gov. Besides as required by regulation, the Firm undertakes no responsibility or obligation to replace any forward-looking statements contained on this launch because of new data, future occasions, modifications in expectations or in any other case.
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|
Thoughts Drugs (MindMed) Inc. Condensed Consolidated Statements of Operations and Complete Loss (Unaudited) (In 1000’s, besides share and per share quantities) |
||||||||
|
Three Months |
||||||||
|
2023 |
2022 |
|||||||
|
Working bills: |
||||||||
|
Analysis and improvement |
$ |
12,599 |
$ |
10,241 |
||||
|
Basic and administrative |
8,263 |
8,264 |
||||||
|
Whole working bills |
20,862 |
18,505 |
||||||
|
Loss from operations |
(20,862 |
) |
(18,505 |
) |
||||
|
Different earnings/(expense): |
||||||||
|
Curiosity earnings/(expense), web |
1,284 |
(27 |
) |
|||||
|
International alternate achieve/(loss), web |
(52 |
) |
45 |
|||||
|
Change in honest worth of 2022 USD Financing Warrants |
(5,185 |
) |
— |
|||||
|
Different earnings |
— |
36 |
||||||
|
Whole different earnings/(expense), web |
(3,953 |
) |
54 |
|||||
|
Web loss |
(24,815 |
) |
(18,451 |
) |
||||
|
Different complete loss |
||||||||
|
Achieve/(loss) on international forex translation |
14 |
(49 |
) |
|||||
|
Complete loss |
$ |
(24,801 |
) |
$ |
(18,500 |
) |
||
|
Web loss per widespread share, fundamental and diluted |
$ |
(0.65 |
) |
$ |
(0.66 |
) |
||
|
Weighted-average widespread shares, fundamental and diluted |
38,077,251 |
28,147,499 |
||||||
|
Thoughts Drugs (MindMed) Inc. Condensed Consolidated Stability Sheets (In 1000’s, besides share quantities) |
||||||||
|
March 31, 2023 |
December 31, |
|||||||
|
Property |
||||||||
|
Present belongings: |
||||||||
|
Money and money equivalents |
$ |
129,409 |
$ |
142,142 |
||||
|
Pay as you go and different present belongings |
3,004 |
3,913 |
||||||
|
Whole present belongings |
132,413 |
146,055 |
||||||
|
Goodwill |
19,918 |
19,918 |
||||||
|
Intangible belongings, web |
2,898 |
3,689 |
||||||
|
Different non-current belongings |
300 |
331 |
||||||
|
Whole belongings |
$ |
155,529 |
$ |
169,993 |
||||
|
Liabilities and Shareholders’ Fairness |
||||||||
|
Present liabilities: |
||||||||
|
Accounts payable |
$ |
2,320 |
$ |
2,111 |
||||
|
Accrued bills |
6,687 |
5,877 |
||||||
|
2022 USD Financing Warrants |
15,089 |
9,904 |
||||||
|
Whole present liabilities |
24,096 |
17,892 |
||||||
|
Different liabilities, long-term |
1,089 |
1,184 |
||||||
|
Whole liabilities |
25,185 |
19,076 |
||||||
|
Commitments and contingencies |
||||||||
|
Shareholders’ Fairness: |
||||||||
|
Frequent shares, no par worth, limitless licensed as of March 31, 2023 and December 31, 2022; 38,290,111 and 37,979,136 issued and excellent as of March 31, 2023 and December 31, 2022, respectively |
— |
— |
||||||
|
Further paid-in capital |
348,986 |
344,758 |
||||||
|
Accrued different complete earnings |
641 |
627 |
||||||
|
Accrued deficit |
(219,283 |
) |
(194,468 |
) |
||||
|
Whole shareholders’ fairness |
130,344 |
150,917 |
||||||
|
Whole liabilities and shareholders’ fairness |
$ |
155,529 |
$ |
169,993 |
||||
View supply model on businesswire.com: https://www.businesswire.com/information/residence/20230504005909/en/
Contacts
For Media & Investor Inquiries, please contact:
Maxim Jacobs, CFA
Vice President, Investor Relations and Company Communications
Thoughts Drugs (MindMed) Inc.
[email protected]
[email protected]
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